Goserelin Boston Biopharma 10.8mg implant in a Pre-filled Syringe

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

GOSERELIN ACETATE

Verfügbar ab:

Boston Biopharma Limited Malta Life Sciences Park, Building 2, Level 0, San Gwann SGN 3000, Malta

ATC-Code:

L02AE03

INN (Internationale Bezeichnung):

GOSERELIN ACETATE

Darreichungsform:

IMPLANT

Zusammensetzung:

GOSERELIN ACETATE 10.8 milligram(s)

Verschreibungstyp:

POM

Therapiebereich:

ENDOCRINE THERAPY

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2019-04-03

Gebrauchsinformation

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
GOSERELIN BOSTON BIOPHARMA 10.8 MG IMPLANT, IN A PRE-FILLED SYRINGE
Goserelin
Read all of this leaflet carefully before you start using this
medicine because it contains important
information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Goserelin Boston Biopharma 10.8 mg is and what it is used for
2.
What you need to know before you useGoserelin Boston Biopharma 10.8 mg
3.
How to use Goserelin Boston Biopharma 10.8 mg
4.
Possible side effects
5.
How to store Goserelin Boston Biopharma 10.8 mg
6.
Contents of the pack and other information
1.
WHAT GOSERELIN BOSTON BIOPHARMA 10.8 MG IS AND WHAT IT IS USED FOR
Goserelin Boston Biopharma 10.8 mg contains a medicine called
goserelin. This belongs to a group
of medicines called ‘LHRH analogues’. Goserelin Boston Biopharma
10.8 mg is a long-acting form
of Goserelin Boston Biopharma 3.6mg and it is given every 12 weeks
Goserelin Boston Biopharma 10.8 mg is used to treat prostate cancer.
It works by reducing the
amount of ‘testosterone’ (a hormone) that is produced by your
body. .
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN GOSERELIN BOSTON BIOPHARMA
10.8 MG
DO NOT USE GOSERELIN BOSTON BIOPHARMA 10.8 MG:
•
if you are allergic to goserelin or any of the other ingredients of
this medicine (listed in
section 6).
•
you are a woman.
Do not have Goserelin Boston Biopharma 10.8 mg if any of the above
apply to you. If you are not
sure, talk to your doctor or

Fachinformation

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Goserelin Boston Biopharma 10.8 mg implant, in a pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One implant contains 10.8 mg goserelin (as goserelin acetate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implant, in a pre-filled syringe
White to off-white cylindrical rods (approximate dimensions: diameter
1.5 mm, length 13 mm, mass
44 mg), embedded in biodegradable polymer matrix.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Goserelin Boston Biopharma is indicated (see also section 5.1):
-
In the treatment of metastatic prostate cancer where goserelin has
demonstrated comparable
survival benefits to surgical castrations (see section 5.1).
-
In the treatment of locally advanced prostate cancer, as an
alternative to surgical castration
where goserelin has demonstrated comparable survival benefits to an
anti-androgen (see
section 5.1).
-
As adjuvant treatment to radiotherapy in patients with high-risk
localised or locally advanced
prostate cancer where goserelin has demonstrated improved disease-free
survival and overall
survival (see section 5.1).
-
As neo-adjuvant treatment prior to radiotherapy in patients with
high-risk localised or locally
advanced prostate cancer where goserelin has demonstrated improved
disease-free survival (see
section 5.1).
-
As adjuvant treatment to radical prostatectomy in patients with
locally advanced prostate
cancer at high risk of disease progression where goserelin has
demonstrated improved disease-
free survival (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult males _
One depot of Goserelin Boston Biopharma injected subcutaneously into
the anterior abdominal wall
every 3 months (see section 5.1 Pharmacodynamic properties).
_Elderly _
No dosage adjustment is necessary in the elder